opportunity cost of cancer care nice statement
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8/11/2019 Opportunity Cost of Cancer Care NICE Statement
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Comment
www.thelancet.com/oncology Vol 12 September/October 2011 931
The opportunity cost of cancer care: a statement from NICE
The Lancet Oncologys commissioned report on deliver-
ing affordable cancer care in high-income countries
valiantly attempts to outline how developed countries
might deliver reasonably priced cancer care to all their
citizens.1 Even with its narrow ocusomitting people
with cancer in lower and middle income countries and
neglecting preventive measuresit has merit.
There are, unquestionably, parts o the report that
comprise a thorough, evidence-based review o available
data on the development and use o effective treaments
or cancer. The section on affordable cancer surgery(Part 4), or example, provides a thoughtul discussion
in an area that has been neglected. However, there are
three issues with which we take exception.
The first issue is the cost o new anticancer drugs.
The report does not adequately address the underlying
reasons or the increasing costs o anticancer drugs.
Over the past 40 years the median monthly costs, at
launch (and adjusted to 2007 prices), has risen rom
less than US$100 in 196569 to more than $5000 in
200509.2Why?
The cost o developing new drugs, generally, has
increased substantially over the past decades and is
becoming unsustainable.3,4 This is partly due to the
escalating costs and ineffi ciencies o clinical trials
themselves, together with the increasing additional
burdens imposed by national drug regulatory
authorities. The lengthening development times, and
resulting erosion o products patent lives, mean that
companies must necessarily charge high prices to
recoup their investment in research and development.
Moreover, drug discovery is becoming more diffi cult.
The sums spent on research and development have
increased three times over the past two decades but,
as judged by the number o drugs licensed per dollar o
research and development, the innovative perormance
o the drug industry has declined.5
Even more importantly, the pharmaceutical industry
aces a very substantial loss o income over the next
4 years, as a result o the loss o patents on many o its
blockbusters. For example, analysts6predict that in the
USA, sales o branded medicines will all by $42 billion
in 201112. To offset this loss o income the industry is
charging premium prices or its newer products.
A second issue is that in several places the reportis critical o health technology assessment (HTA)
agencies. None (including the National Institute or
Health and Clinical Excellence [NICE] in the UK) are
perect and it is true that incompetent agencies could
do great harm to patients. Nevertheless, some o the
criticisms are purely polemic and without an evidence
base to support them. For example, in Part 2, it is
claimed that NICEs decisionsunlike those in Scotland
and Northern Irelandare economist directed rather
than physician led. Aside rom the act that Northern
Ireland does not have its own arrangements or
appraising new interventions, and relies on advice rom
NICE, NICEs appraisal committees mainly comprise
clinicians working in the National Health Service with
each committee having only two or three economists
among its 25 members.
The third issue is that the report takes too little
account o the opportunity costs oten incurred by
use o some expensive new anticancer drugs that
offer modest benefits. Countries seeking to provide
universal access to health care or all citizens have finite
resources at their disposal. These resources have to
meet the needs o people with cancer and all those
*Francesco Pignatti, Xavier Luria, Eric Abadie,
Hans-Georg EichlerEuropean Medicines Agency, London, UK (FP, XL, H-GE);
Committee or Medicinal Products or Human Use, Agence
Franaise de Scurit Sanitaire des Produits de Sant, Saint-Denis,
France (EA)
FP, XL, and H-GE are employed by the European Medicines Agency.
The views expressed in this article are the personal views o the authors and do
not necessarily reflect those o the European Med icines Agency, or one o its
committees or working parties.
See The Lancet Oncology
Commissionpage 933
1 Eichler HG, Pignatti F, Flamion B, Leufens H, Breckenridge A. Balancing
early market access to new drugs with the need or benefit/risk data:a mounting dilemma. Nat Rev Drug Discov 2008; 7:81826.
2 Sullivan R, Peppercorn J, Sikora K, et al. Delivering affordable cancer care inhigh-income countries. Lancet Oncol2011; 12:93380.
3 Eichler HG, Abadie E, Breckenridge A, et al. Bridging theeffi cacy-effectiveness gap: a regulators perspective on addressin gvariability o drug response. Nat Rev Drug Discov2011; 10:495506.
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8/11/2019 Opportunity Cost of Cancer Care NICE Statement
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Comment
932 www.thelancet.com/oncology Vol 12 September/October 2011
with other health conditions. Moreover, resources
will become even more constrained as a result othe financial diffi culties acing almost all developed
countries.
The problem is simple yet real. I large (and
increasing) sums o a health-care systems finite
resources are to be devoted to cost-ineffective cancer
care, then other patients with other diseasesoten
lacking the vocal support o pharmaceutical companies
and patient advocacy groupswill be denied access
to cost-effective care. The solution to this over-riding
problem is one we all need to seek.
The commissioned report offers little in the way oeffective solutions. The list in table 7 does not get to the
heart o the matter. What is needed is or new, effective
anticancer treatments to be priced at a level that is
affordable in a cold economic climate. This requires the
industry to operate in a much more effi cient manner,
or the costs o drug development to be slashed, and
or oncologists and patient advocacy groups to start
asking tough questions o both regulators and the
pharmaceutical industry.
We have some suggestions or practical imple-
mentation o effective solutions. First, recentproposals by an international group o academic
clinical investigators suggest that clinical trial costs
could be decreased by 4060% without detriment
to their quality.7,8 Simple measures to reduce costs
include electronic data capture, reduction in the
length o case-management orms, and modified
site-management practices. The latter should include
greater use o statistical techniques to detect raud,
rather than over-reliance on site visits by regulators
and sponsors.9 Second, greater use o Bayesian
techniques in the design and analysis o randomised
controlled trials3,4 holds real promise in reducing trial
duration and numbers o patients needed. Third,
oncologists and patient advocacy organisationsshould start challenging the data requirements
demanded by regulatory authorities. Fourth, rather
than criticise organisations such as NICE or declining
reimbursement on grounds o cost-effectiveness,
clinicians and patient advocates should start
challenging pharmaceutical companies about the high
prices they seek or products with modest benefits.
Finally, we should all be more concerned about the
diffi culties acing low and middle income countries in
accessing affordable cancer care, rather than constantly
ocusing on the problems acing developed countries.
*Michael D Rawlins, Kalipso ChalkidouNational Institute or Health and Clinical Excellence, London, UK
Both authors are employed by the National Institute or Health and Clinical
Excellence.
1 Sullivan R, Peppercorn J, Sikora K, et al. Delivering affordable cancer carein high-income countries. Lancet Oncol2011; 12:93380.
2 Bach PB. Limits on Medicares ability to control rising spending on cancerdrugs. N Engl J Med2009; 360:62633.
3 Rawlins MD. Cutting the cost o drug development? Nat Rev Drug Discov2004; 3:36064.
4 Rawlins MD. De testimonio: on the evidence or decisions about theuse o therapeutic interventions. London: Royal College o Physicians,
2008.
5 Congress ional Budget Offi ce. Research and developme nt in thepharmace utical indus try. Congressional Budget Offi ce: Washington DC,2006.
6 Research and Markets. US pharmaceutical market overviewhealthcarereorm, economic pressures and the patent cliff set to impact pharma.http://www.researchandmarkets.com/reports/1383066/ (accessedJuly 29, 2 011).
7 Eisenstein EL, Lemons PW, Tardiff BE, et al. Reducing the costs o phaseIII cardiovascular trials.Am Heart J 2005; 149:48288.
8 Eisenstein EL, Collins R, Cracknell BS, et al. Sensible approaches orreducing clinical trial costs. Clin Trials 2008; 5:7584.
9 Buyse M, George SL, Evans S, et al. The role o biostatistics in theprevention, detection and treatment o raud in clinical trials.Stat Med1999; 18:343551.